Community Health Worker And MHealth to ImProve Viral Suppression

Not Applicable

Completed

Interventions: Device: Wise App with medication adherence reminders
Behavioral: CHW Sessions

Brief Summary: The overall goal of this study is to evaluate the effects of the CHAMPS intervention for people living with HIV (PLWH) in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a combined community health worker (CHW) and smartphone intervention linked to a smart pill box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a rigorous theoretical model of supportive accountability and building on preliminary work, this intervention has the potential to enable PLWH to self-manage their ART regimens while CHW monitor their ART adherence in real-time ultimately leading to viral suppression and ART adherence.

Detailed Description: Persons living with HIV (PLWH) now achieve a near-normal life expectancy due to antiretroviral therapy (ART) which has transformed HIV from a terminal diagnosis to a manageable chronic condition. Despite widespread availability of ART in the United States (US), many of the country's approximate 1.1 million PLWH are not fully benefitting from ART due to poor adherence. These suboptimal HIV health outcomes occur at a time when clinicians have limited time and the US healthcare system remains fragmented, further exacerbating the challenges inherent in the lives of underserved, marginalized groups, such as PLWH. Therefore, the development and evaluation of interventions using a cadre of community health workers (CHW) holds promise for addressing these challenges in the US. This study addresses limitations in current research on CHW interventions to improve viral suppression and ART adherence. The investigators propose to build on strong preliminary data to strengthen a community health worker (CHW) intervention using an existing mHealth approach, and provide further information regarding the successful wide-scale implementation of this combination intervention.

Recruitment & Eligibility

Inclusion Criteria

Be able to communicate and read in English or Spanish
Willing to participate in any assigned arm of the intervention
Diagnosed with HIV ≥6 months ago
Have an HIV-1 RNA level >200 copies/mL, or have at least one "no-show" visit in the past 12 months, or report being virally unsuppressed in the past 12 months
Have ART adherence <80%, as measured through Single-Item Self-Rating Adherence Scale (SRSI)
Own a smartphone

Exclusion Criteria

Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment
Terminal illness with life expectancy <6 months
Planning to move out of the area in the next 12 months

Arm && Interventions

Group	Intervention	Description
Intervention	Wise App with medication adherence reminders	Wise App that delivers medication adherence reminders and community health worker sessions
Intervention	CHW Sessions	Wise App that delivers medication adherence reminders and community health worker sessions

Primary Outcome Measures

Name	Time	Method
Number of Virally Suppressed Participants	6 month follow up, 12 month follow up	The number of virally suppressed participants. Viral suppression defined as viral load of \<200 copies/mL.

Secondary Outcome Measures

Name	Time	Method
Antiretroviral Therapy (ART) Adherence - CleverCap	Up to 12 months	The CleverCapTM dispenser will automatically record each time a participant opens the dispenser. The investigators will collect adherence data each day from the start to the end of trial (day 1 to 12 months) and report the number of days used.
Change in Score on the Self-Rating Scale Item (SRSI)	6 month follow up and 12 month follow up	The Self-Rating Scale Item is a single-item self-report adherence measure that uses a 5-point Likert scale to describe medication adherence over the past 4 weeks. Scores range from 1(very poor) to 6 (excellent).

Locations (3): Birmingham AIDS Outreach
🇺🇸
Birmingham, Alabama, United States
Columbia University Irving Medical Center
🇺🇸
New York, New York, United States
University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States